Devices and methods for increased blood flow and pain control

ABSTRACT

A device comprising a casing; at least one vibratory source; at least one power source; at least one switch to actuate the vibratory source; electrical communication between the vibratory source, the power source, and the switch; and an optional thermal element for modulating the temperature of a contacted area of a surface. Also disclosed herein are methods for using the device.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/426,330 filed Mar. 21, 2012, which is a continuation of U.S.Pat. No. 8,147,533 filed Oct. 4, 2006, and issued Apr. 3, 2012, each ofwhich is herein incorporated in its entirety.

TECHNICAL FIELD

The present invention generally relates to devices and methods for theimprovement of circulation, for example in blocked ducts, veins orarteries, and for pain control and irritating sensation control, such asitching and burning, by interfering with transmission of nerve signalsby, for example, aDelta nerves, using devices capable of vibrationand/or thermal effects.

BACKGROUND

Vibration has long been used to decrease the pain of dental injections,but vibrating needles have not been found to be effective in otherdermal situations. Use of a simple hand-held vibrating massager hasdecreased injection pain in adults, and with the adjuvant of coldtherapy was tested in both children and adults and found to relieve pain(Baxter et al. 2011; Baxter et al. 2009; Inal and Kelleci 2012).

Increasing vein diameter (vasodilation) is extremely important forvenipuncture in children, as well as for circulation in adults.Venipuncture success in emergency department is regularly found to bebetween 55 and 65% (Taddio et al. 2005; Spandorfer et al. 2005) and canbe as low as 49% in children (Hess 2010).

Devices in the prior art that have sought to induce vasodilation haveused dramatically different means, including electrical stimulation andsubsequent muscle contraction (US 2011/0071595), vacuum suction (U.S.Pat. No. 5,454,778), and compression (U.S. Pat. No. 6,129,688).Moreover, none of these devices are intended for increasing the successof venipuncture or reducing pain and discomfort associated with lowblood flow.

Therefore, there is a need for an intentional agent (device and/ormethod) to increase vasodilation contributing to the success ofvenipuncture, improve blood flow for healing, and decrease claudication(pain from inadequate blood flow), which would include both vibrationstimulation and a shape suitable to conform to the body. Such a deviceshould be reusable, easy to clean, tolerable to children and adults, andshould incorporate a method to be adapted for use in the developingworld (for example, operation with a power cord, with a battery, with asolar or light cell, or without the need for external power). As ease ofuse is critical in this environment, embodiments that includerechargeable options, moveable locations, optional numbers of vibrationunits, or the option to include cold or heat also are contemplated.

Accordingly, there is a need for a device method that allows for thelocal improvement of blood flow, improvement of circulation in blockedducts, veins or arteries, and for pain control and irritating sensationcontrol. There also is a need for a device and method using vibration ora combination of vibration and thermal element that is applied to asubject prior to and/or during the provision of medications that createa burning or itching sensation when administered to a subject. It is tothese needs and others that the present invention is directed.

SUMMARY

The present invention comprises methods and devices for increasing localblood flow and flow through ducts, veins or arteries, and for paincontrol and irritating sensation control, such as itching and burning,by interfering with transmission of nerve signals by, for example,aDelta nerves, using devices capable of vibration and/or thermaleffects. A method of the present invention comprises contacting a deviceof the present invention near or at a site of restricted blood flow, forexample, to small veins or a site of vasospasm, initiating vibrationand/or thermal effects, for a time sufficient to effect an increase inthe diameter of the blood vessels, such as veins or arteries, andreducing the blockage in ducts.

A method of the present invention comprises reducing the pain orirritating sensation, such as those caused by an injected medication,comprising contacting a device of the present invention between thespinal cord and the site where the pain or irritating sensation isinitiated, such as a site of injection of a medication that causes aburning or painful sensation when injected; initiating vibration by thedevice in an intermittent or continuous vibration, optionally applyingcold simultaneously with the vibration, vibrating for a sufficient timeto interfere with nerve transmission as the injection is occurring,moving the device to the site of injection once the medication ininjected, and initiating vibration at the injection site for a timesufficient to reduce the pain felt from the injection site optionallyapplying cold simultaneously to the injection site, to interfere withtransmission of pain signals by aDelta nerves. The sensations from aninjected medication, such as burning or itching, are different fromthose produced by needle stick pain, and the burning and/or itchingsensations are not found with all medications, whereas needle stick painis generally found with all injections or needle sticks.

A method of the present invention comprises reducing an itchingsensation in an animal, comprising contacting a device of the presentinvention to a site of itching, initiating vibration by the device,optionally applying a thermal effect simultaneously with the vibration,and reducing the sensation of itching, for example, by interfering withthe transmission of nerve signals by aDelta nerves at the site ofitching.

A method of the present invention comprises treating blocked mammaryducts, comprising, contacting a device of the present invention at oradjacent to a site of a blocked mammary duct, initiating vibration bythe device, optionally providing a thermal effect simultaneously withthe vibration, and modulating the condition of the blocked duct, forexample, by at least releasing a portion of the blockage and/orrelieving the pain caused by the blockage.

A device of the present invention comprises a casing, which may beshaped to conform to the contour of a surface, that contains a vibratoryelement, an optionally a thermal element. In an aspect, a casing or atleast one surface of a casing, is shaped to fit a curved surface of thebody. For example, one surface of a casing may be concave, shaped likethe inner surface of a circle, and when the device contacts a surface,such as an arm, the concave surface of the casing substantially contactsthe arm surface, meaning that a majority of the concave surface is incontact with the area of the surface. This contact of substantially theentire concave surface of the device allows for enhanced transfer ofvibration and/or thermal effect to the surface. Vibration effects can beprovided by any of the known vibratory devices such as, for illustrativepurposes, a vibratory motor provided within the casing. Once vibrationis initiated by providing power to the vibratory source, such as avibratory motor, the vibration may be constant and continual, or thevibration may be intermittent, and cycle on and off at the same or adifferent vibration speed or frequency. Though not wishing to be boundby any particular theory, it is believed that intermittent vibration mayaid in reducing or preventing habituation by the body to the vibrations.

An exemplary embodiment of the device comprises a casing housing thevarious components of the invention and an optional strap for holdingthe device to the subject. The casing may be manufactured of a stiffmaterial to transmit vibration, and may be placed into a more flexibleor pliant material in the form of a covering. The casing can be anyshape, and preferably conforms to most body parts, particularly fingers,arms, and legs. For example, an application area may be concave orconvex so conform to rounded areas of the body to which the device maybe applied. Any other shape may be employed, so long as the shape islarge enough and structured so as to be able to contain the variousworking components of the invention. A device of the present inventionmay optionally comprise an adhesive area on a portion or substantiallyall of the proximal side of an application area or a thermal element foraffixing the proximal side of the casing/thermal element to a surface,such as the body or skin of a subject.

A method of the present invention comprises providing a device of thepresent invention externally to the skin surface of a subject. Forexample, the subject may be a human or animal to whom a hypodermicneedle is being applied to either remove fluid from the subject or toinject a composition into the subject. The vibratory device of thepresent invention may be placed at a site of injection, pain, itching,burning, blocked vessels, or may be placed proximal to such sites. Insome methods, the vibratory device is placed at one site for a period oftime and then moved to a second site. Methods of the present inventionallow for increased blood flow, reduction of pain, reduction ofirritating or unpleasant sensations, such as itching or burning,increased healing, or for blood drawing or injection procedures.

These features, and other features and advantages of the presentinvention will be apparent to those of ordinary skill in the relevantart when the following detailed description of the preferred embodimentsis read in conjunction with the appended drawings in which likereference numerals represent like components throughout the severalviews. The figures and the detailed description which follow moreparticularly exemplify these and other embodiments of the invention.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying Figures, which are incorporated in and constitute apart of this specification, illustrate several aspects and together withthe description serve to explain the principles of the invention.

FIG. 1 is a perspective view of an embodiment of the invention. In theview, the device (10) is being applied to the arm (100) of a subjectwith an initiation site (104), which is a site of pain, or irritatingsensation, such as burning or itching. The positioning of the device(10) on the subject is between the initiation site (104) and a nerveplexi (not shown, but the location of which is known to those ofordinary skill in the pain alleviation field) such as between theinitiation site (104) and the proximal joint, in this case the elbow(E). Thus, for the illustrated initiation site (104) on a subject's arm(100), the device (10) is placed closer to the elbow (E) than to thewrist (W) as this location puts the device (10) in between theinitiation site (104) and the subject's brain. For example, the device10 may be placed approximately 2.5 cm to 15 cm from initiation site(104).

FIG. 2 is a top view of an embodiment of the invention with bothvibration and cold capabilities. A minimal embodiment of the externalfeatures of the invention comprises the casing (12) and an on/off switch(16). Optional strap (14) can be used to hold the device on to thesubject. Strap 14 can be attached to the casing (12) in any conventionalmanner or can be an extension of casing (12) itself. The ends of strap(14) preferably have some type of connecting device (18), such as a hookand loop fastener, a clasp, a clip, snaps, magnets, adhesive, or thelike for attaching the device about the subject's body part.Alternatively, if the ends of strap (14) are flexible, the ends can betied together around the subject's body part. The casing (12) of adevice may be curved in a manner to enhance the attachment of the deviceby a strap or wrap.

FIG. 3 is a bottom view of an embodiment of the invention with bothvibration and cold capabilities. The casing (12) has a peripheral bottomrim (20) that defines an application area generally designated (22).Application area (22) comprises thermal area (24) and vibration area(26). Although thermal area (24) and vibration area (26) area shown asdiscrete areas, this is for illustrative purposes only, as there neednot be any physical delineation between thermal area (24), vibrationarea (26), and application area (22) and these areas can overlap and becoexistent as the same area, which may be referred to as applicationarea (22). Thermal element (28) cooperates with thermal area (24) toapply cold or heat to the subject, and vibrational source (32) (notshown) cooperates with vibration area (26) to apply vibration to thesubject. Thermal area (24) and vibrational area (26) can occupy the samearea, and form application area (22). Thermal element (28) may belocated within thermal element pocket (34).

FIG. 4 is sectional side view of the embodiment of the invention asshown along the latitudinal line 4-4′ of FIG. 2. The casing (12) is agenerally hollow structure sized to contain a thermal element (28) and avibrational source (32). Thermal element (28) can be placed withinthermal element pocket through mouth or opening (36) and can be heldwithin thermal element pocket (34) by friction, adhesives, fasteners, orby a zipper or other type of closure on mouth or opening (36). It ispreferable that the bottom wall (38) of thermal element pocket (34) besufficiently thin or having sufficient thermal transfer characteristicsso as to allow the efficient transfer of cold or heat from thermalelement (28) to the subject. The vibrational source (32) furthercomprises a power source (40) and wiring (42) electrically connectingvibrational source (32) and power source (40) to on/off switch (16).

FIG. 5A is a circuit diagram of an embodiment of the invention. Arepresentative circuit diagram for the vibrational source (32) is shown.The vibrational source (32), power source (40), and on/off switch (16)are electrically connected in series by wiring (42). FIG. 5B is acircuit diagram of an embodiment of the present invention comprising avibrational source (32), a push button on/off switch (16), a batterypower source (40), a control board (45), and optionally a speaker (46)and a light (47), in electrical connection in series by wiring (42).

FIG. 6 is a perspective view of an embodiment of the invention having anornamental cover (60) or a decorated casing (12). The device is depictedin the same use as FIG. 1 with the addition of an ornamental cover (60)or a decorated casing (12) for the purpose of distracting the subject,preferably a child.

FIG. 7 is a drawing of the rear view of an exemplary device of thepresent invention showing the application area (22) of a device (10)comprising the proximal side (30) of the casing (12) and the proximalside (29) of a (transparent) thermal element (28) coextensive with theapplication area wherein thermal element (28) associated with theproximal side of casing (12) by use of an attachment element (50), whichis an elastic band in this figure.

FIG. 8 is a drawing of an exemplary vibratory device of the presentinvention wherein the device is placed between the initiation site (104)of pain, burning, itching, or injury and the spinal cord.

FIG. 9A-E shows a drawing of an exemplary device of the presentinvention having a concave shaped casing. A shows the front or anteriorend (31) of the device (10) and its power switch (16), B shows theposterior or rear end (33) of the device (10) with its site indicator(52), and C shows the back or proximal side (30) of the device, that iscontacts, or is placed proximally or adjacent to, the surface, having aclip (50) for holding a thermal element (not shown) in place; D shows afront or distal side (37) of the device (10), and E shows a side view(35 a or 35 b) of the vibratory device (10) where the attachment element(50) a clip, slightly protrudes from the posterior (lower) (33) proximalend and the on/off switch element (16) is shown at the anterior (upper)end (31).

DETAILED DESCRIPTION

The present invention comprises devices and methods for reducing pain orsensation, and for increasing blood or fluid flow in local areas. Anembodiment of a device of the invention comprises a casing that containsa vibrational source, and an on/off switch for the vibrational source. Adevice may further comprise an attachment element for holding a thermalelement in association with the casing. An attachment element (50) maybe an integral portion of the casing, such as the clip shown in FIG. 9,or may be itself attached to the casing, such as the attachment element(50) shown in FIG. 7. An optional strap or wrap can be used to hold thedevice on to the subject, for example a strap that extends around a limbof the subject to secure the device on the limb of the subject such thatthe medical practitioner need not have an assistant present to hold thedevice, so that the medical practitioner can have both hands free totreat the subject, or a larger wrap that secures the vibratory device toa limb or body structure, for example, for an extended time. Further, astrap can act as a tourniquet, if necessary. Alternatively, the devicecan be held against the subject by the practitioner, the practitioner'sassistant, or the subject.

A casing of a device of the present invention comprises an applicationarea that comprises an optional thermal area and a vibrational area. Theapplication area is the portion of the casing for contacting the surfaceor for contacting a thermal element that in turn contacts the surface.For simplicity of understanding, the surface may be referred to as theskin of a subject. In an aspect, the application area may be all or aportion of the proximal side of a vibratory device. A thermal elementcooperates with the thermal area to apply cold or heat to the subject,and a vibrational source cooperates with the vibrational area to applyvibration to the subject. The placement of the thermal element isvariable so long as the effects of the thermal element can be felt onthe subject so as to produce thermal vasodilation or vasoconstriction.The placement of the vibrational source in the casing is variable solong as the vibrational effects of the vibrational source can be felt onthe subject so as to produce vibrational vasodilation or is effective instimulating nerves so that a pain or sensation message is blocked orinterfered with in reaching the spinal cord nerves, and interfering withthe perception of the pain or sensation by the subject. The walls of thecasing define an interior space that is sized to contain at least thevibrational source, and a power source, such as batteries, andoptionally a control element, a thermal element, a sound element, or alight element, and wiring to connect at least the vibrational source andthe power source. An attachment element, a clip or hook on the proximalside (30), facing the subject surface, may be used to secure a thermalelement to the device. An attachment element, such as an elastic bandmay also be used to secure the thermal element to the proximal side of adevice of the present invention. Adhesive on the proximal side of thecasing may be used to hold a thermal element to a device. A casing mayfurther contain a control element for controlling the speed of vibrationor period of vibration, for storing and providing sound, for providing atiming element, for controlling a light, such as turning a light on oroff, with or without a timer, or making the light blink at a particulartime point

Devices and decorative casings, and the use of distractive media aredisclosed in U.S. Pat. No. 8,147,533 filed Oct. 4, 2006, and issued Apr.3, 2012, U.S. patent application Ser. No. 11/867,630, filed Oct. 4,2007; Ser. No. 12/371,206, filed Feb. 13, 2009; and Ser. No. 13/426,330,filed Mar. 21, 2012, each of which is herein incorporated in itsentirety.

A casing may further comprise on opening through a wall of the casingfor providing an amplifier on the outer surface of the casing that isconnected to a control element or a sound element contained within thecasing. A casing may further comprise on opening through the casing forproviding a light, such as an LED light, on the outer surface of thecasing that is connected to a control element or a timing elementcontained within the casing. A light (and/or sound) may be turned onwhen vibration is initiated and turned off when power to the vibrationelement is turned off. Alternatively, powering on the vibration elementmay also power on a timing element, and optionally a light (and/orsound), so that when a desired time period has occurred, the timingelement may turn off the light (and/or sound), or may turn off a light(and/or sound) and the vibration element, or the timing or controlelement may turn on sound or light after a period of vibration.Alternatively, the timing element may be under a control that isseparate from a control for the vibration element. Components forswitches, control elements, such as a polycarbonate circuit board andthe programming to accomplish the disclosed activities and others, andelements such as timing elements, sound elements and lights, are known,and can be selected or commercially acquired by those of skill in theart. Wires for connecting the elements within the casing or on thesurface are contemplated by the present invention.

The casing may be shaped to provide an application area that is incontact with a surface so that substantially all of the application areacontacts the surface. For example, a casing may be flat or concave inshape on at least its proximal side so that the application area isshaped so that substantially all of the proximal side of the casingcontacts the surface of the surface. When a thermal element is placed onthe proximal surface of the casing, substantially all of the proximalsurface of the casing contacts the thermal element interposed betweenthe casing outer surface and the contacted surface so that an area ofthe surface that is equivalent to the area of substantially all of theproximal side of the casing is contacted by the thermal element andreceives vibrational effects therethrough (the application area). All ora portion of a casing may be curved. For example, the entire casing maybe curved, such as in a concave direction (curved like the interior of acircle), so that the proximal side of the casing is contacting a surfacethrough all or a portion of its surface (or the thermal elementinterposed therebetween) and the distal side (37) of the casing iscurved to mirror the curve of the proximal side, so as to be comfortablyheld by a hand or held in place by a strap. Alternatively, only onesurface, either the distal or proximal side may be curved, for example,where the proximal side is flat, but the distal side is curved.Additionally, a proximal side and/or a distal side of the casing may beflat or planar, and the lateral sides (35 a or 35 b) of the casing maybe shaped, for example, as shown in FIGS. 7 and 9, there may be anindented area in the lateral sides. The lateral sides of the casing maybe shaped in any form desired.

A casing may further comprise an adhesive area on a portion orsubstantially all of the application area. In an aspect, an adhesivearea may be found on the proximal side of a thermal element and maycover a portion or substantially all of an area on the proximal side ofthe thermal element that corresponds to the application area of adevice. A device of the present invention may optionally comprise anadhesive area on a portion or substantially all of the proximal side ofthe application area of the casing or the thermal element for attachingthe proximal side of the device/thermal element to a surface, such asthe body or skin of a subject. On the casing and/or thermal element andbefore use, the adhesive area may be covered by a removable shield. Inuse, the removable shield is removed from the adhesive area on theproximal side of the casing and/or thermal element so that the adhesiveis exposed and is capable of affixing the proximal side of a casing to athermal element or to a surface, such as skin, or is capable of affixingthe proximal side of a thermal element to a surface.

The vibrational source can be any conventional vibrational source ormeans for producing high frequency low amplitude vibrations. The on/offswitch can be a common switch or a push button on/off switch, and isused to turn the vibrational source on and off. Once turned on, thevibrational source may vibrate in a constant and continuous mode, or thevibrations may be noncontinuous, such as intermittent periods or cyclesof vibration and no vibration. The power source for operating thevibrational source can be any type of power source such as but notlimited to a connection to an alternating current source (a wall plug),a solar or other light cell, a miniature reactor, a mechanical sourcesuch as a flywheel or springs, a disposable or rechargeable battery orthe like.

In a method, a device of the present invention improves blood flow atleast in the area contacted by the device, through the use ofvibrational and/or thermal stimulation of blood and/or lymph vessels, orducts of the body. In response to contacting the skin surface with avibrating and/or thermal device of the present invention, blood flow inareas not specifically contacted by the device, such as blood flow indistal areas, may be improved, for example, in response to the increasedblood flow at or near the site of contact. More specifically, thepresent invention comprises use of a device disclosed herein forconcurrently applying a combination of vibrational effect and thermaleffect to a surface area of a subject. In an aspect, the combinedeffects of vibration and thermal heat effects cause dilation of bloodand/or lymph vessels proximal to the site of application of a device. Inan aspect, the combined effects of vibration and thermal cold effectscause constriction of blood and/or lymph vessels proximal to the site ofapplication of a device. In an aspect, for ducts of the body, forexample, blocked mammary ducts, the combined effects of vibration andthermal heat effects cause a reduction in the transmission of painsignals from the blocked ducts, and also aid in reducing the blockage ofthe duct proximal to the site of application of a device. For example,the effects of vibration and/or thermal application may provide a localphysiological effect to a surface and its underlying ducts or vesselswithin from 0.0 cm to 15 cm from the site of application of the device.Application of the device may have a more systemic effect by triggeringa response in the local area, (0.0 cm to 15 cm) by a body part, such asa nerve, that has effects at a distant location, such as triggering anerve response at the site of application that blocks nerve transmissionof pain or sensation by spinal or other nerves. Local stimulation ofblood, lymph or milk (or a body fluid in a duct) flow by a device of thepresent invention may alter blood, lymph, milk or duct fluid flowresponses in vessels not in the area related to the surface contacted bya device of the present invention. It is known that vibration helps toreduce pain as the vibrational, or motion, nerves surmount the painnerves, which is known as gate theory to those of ordinary skill in thefield. Similarly, it is known that cold helps to reduce pain as thetemperature nerves surmount the pain nerves. It also is known that warmthermal contact is effective at vasodilation. Stimulation of aDeltanerves, which is accomplished by a device of the present invention, mayaid pain reduction, which may relax tenses muscles.

Though not wishing to be bound by any particular theory, it believedthat vibrational effects may act to cause release of endogenous nitricoxide which increases lumen diameter. Use of a vibratory device of thepresent invention aids in the removal of blocked ducts, such as mammaryducts in breastfeeding females, blocked passages such those seen inpulmonary disease, for example, in subjects with cystic fibrosis, orarteries, veins and capillaries in tissues with blocked blood flow. Amethod of the present invention comprises treating a subject with cysticfibrosis to open blocked pulmonary ducts or passages, comprisingcontacting at least one site on the outer surface of the body overlyingthe lungs, bronchi or trachea with a device of the present invention,initiating vibration by device for a desired time period, optionallyproviding thermal effects from the presence of a thermal elementinterposed between the device application area and the contacted surfaceof the subject, optionally moving the device and providing vibratoryand/or thermal effects to a second area of the subject, and affecting atleast one pulmonary passage or duct of a subject. For example, in smallhuman infants having blocked pulmonary passages such an infant withcystic fibrosis, a device of the present invention may have a flatproximal side for contacting at least a portion of the thoracic area ofthe infant, whether anteriorly or posteriorly or laterally on thesubject, so that vibratory and/or thermal effects are provided to reduceblocked pulmonary passages and aid in unblocking clogged or blockedpulmonary passages. The gentle and directed vibrational and/or thermaleffects for a controlled time period are beneficial for such blockedpassages.

The present invention comprises methods comprising use of a devicedisclosed herein for increasing local blood flow. The present inventioncomprises methods comprising use of a device disclosed herein forincreasing local lymph flow. The present invention comprises methodscomprising use of a device disclosed herein for increasing local ductfluid flow. A method of the present invention comprises contacting adevice of the present invention to a site of restricted fluid flow, forexample, to a site of small arteries or veins, vessel spasm orvasospasm, or a site of blocked or restricted lymph or duct flow,initiating vibration and/or thermal effects, for a time sufficient toeffect an increase in the diameter of the vessels, such as bloodvessels, such as veins and/or arteries, lymph vessels, and ducts. Forexample, a device of the present invention is provided to an area of thebreast where the duct is blocked. For example, the device, comprisingthe warm thermal element, is placed within bra cup containing the breastand is held in place next to the blocked duct area by the bra. Theswitch is activated so as to turn on the vibration element and the heatand vibrational effects are transmitted to the blocked duct area. Thistreatment causes reduction in pain from the blocked ducts, and reducesthe duct blockage. The treatment may continue for several minutes at atime, wherein vibration and warmth are provided by the device to theblocked duct area, and such treatments may be repeated one or more timesa day for one or more days. With repeated treatment, the extent of theblocked duct is reduced and the blockage may be resolved. With reductionin blockage, pain is also reduced, but the device also functions toblock pain nerve transmissions during treatment.

A method of the present invention comprises reducing the pain or burningsensation caused by injected medication. Many medications, wheninjected, cause a burning or painful sensation at the site of injection.This painful injection is disturbing to the subject receiving theinjection and to the medical staff who provides the medication, andreduction of these side effects of injection would be beneficial forincreased compliance by the subject and reduced stress for the medicalstaff. A method of reducing the pain or burning sensation of an injectedmedication comprises a) contacting a device of the present inventionwith an area on the surface of a subject between the spinal cord and thesite of injection of a medication, that causes a burning or painfulsensation when injected, so that at least a portion of the applicationarea of the device contacts the area; b) initiating vibration by thedevice in an intermittent or continuous vibration, and optionallyapplying a thermal effect simultaneously with the vibration; c) as theinjection continues, so as to inject the medication solution, providingvibrating and/or thermal effect for a sufficient time to interfere withnerve transmission as the injection is occurring; d) once the medicationsolution is injected, moving the device to the site of injection; and e)continuing or initiating vibration and/or thermal effect at theinjection site for a time sufficient to reduce the pain felt from theinjection site. The thermal effect may cold or warm. The device mayinterfere with transmission of pain signals by aDelta nerves at the siteof injection. For example, a subject is injected with a medicationsolution of Lovenox® (enaxaprin sodium) for deep vein thrombosistreatment or in conjunction with in vitro fertilization treatment, in alateral abdominal area. This medication is known to cause pain orburning at injection. Immediately prior to injecting the needle into apinched area of skin (subcutaneously), a device of the present inventioncomprising a cold thermal element is contacted with a first contact sitewhich is the surface of the subject's skin anteriorly/laterally to theinjection site, and within a 5-25 cm range from the site of injection.The device is switched on and continuous vibration and cold is providedto the contacted area. The Lovenox® solution is injected completely intothe site. The device of the present invention is moved from its firstcontact site to the injection site and continuous vibration and cold isprovided to the injection site. Alternatively, continuous vibration maybe provided at the first contact site, and intermittent vibrationprovided at the injection site. Alternatively, intermittent vibrationmay be provided at the first contact site and at the injection site. Thevibration is provided for a desired period, such as until the perceptionof pain is minimal. A medical provider or a user of the device candetermine which type of vibration to use and how long to contact thedevice and/or the thermal element to the skin surface. Lidocaine alsocauses painful or irritating sensations (negative sensations) wheninjected, and injections of lidocaine may also be treated with a deviceof the present invention to relieve the painful and unpleasantsensations from providing the medication.

Methods of the present invention comprise reducing the negativesensations such as burning or itching caused by a medication injectedinto a subject, and such methods include medications that cause suchsensations, not just those listed herein. For example, pharmaceutical ormedical solutions infused into veins may cause pain to subjectsreceiving the solutions. Thought not wishing to be bound by anyparticular theory, it thought that the vibrational and/or thermaleffects provided by a device of the present invention may block nervetransmissions from venous sensory nerves so that the burning and/or painsensations from the infused medical or pharmaceutical solutions to thebrain and/or spinal cord are blocked.

A method of the present invention comprises reducing an itchingsensation in a subject, wherein the itching is localized to one or moreareas. For example, the itching sensation may an acute reaction and becaused by an insect bite or an allergic reaction to contact with asubstance or an injection which creates an irritated area of skin, ormay be a chronic condition caused by constantly irritated nerves such aswith dry skin, eczema or psoriasis, causing an irritated area of skin. Asubject responds to itching by scratching, which may damage skin andlead to infection or permanent scarring of the skin. A method of thepresent invention comprises reducing scratching at a site of skinirritation, comprising a) contacting a device of the present inventionwith an irritated area of skin of a subject; b) initiating vibration bythe device in an intermittent or continuous vibration, and optionallyapplying a thermal effect simultaneously with the vibration; c)continuing the vibration and/or thermal effect at the irritated skinsite for a time sufficient to reduce the itching sensation felt from theirritated skin site. The thermal effect may cold or warm. The device mayinterfere with transmission of pain signals by aDelta nerves at the siteof contact. The irritated skin is the source of the itching sensation. Amethod of the present invention comprises a method of reducing theitching sensation of a subject comprising, a) contacting a device of thepresent invention with an irritated area of skin of a subject; b)initiating vibration by the device in an intermittent or continuousvibration, and optionally applying a thermal effect simultaneously withthe vibration; c) continuing the vibration and/or thermal effect at theirritated skin site for a time sufficient to reduce the itchingsensation felt from the irritated skin site. The thermal effect may coldor warm. The device may interfere with transmission of pain signals byaDelta nerves at the site of the itching sensation. For example, aperson has an area of skin that has eczema on her arm. A device of thepresent invention was kept by the bedside and when an itching sensationwas triggered at the site of eczema of her arm in the night, instead ofscratching the site and damaging the skin, the person contacted thedevice to the site of eczema on her arm, turned on the vibration effectfor a period of 2 to 3 minutes. The device was then turned off, replacedon the bedside table, and the person returned to sleep. Use of thedevice prevented damage to the skin by scratching, and allowed for morerestful sleep by the person.

A method of the present invention comprises treating pain from scrapes,such scrapes from falling on a rough surface, or from pain duringmedical cleaning or scraping of an open wound. When the structure of theskin is disturbed by a scrape, such as a rough abrasion of the skin dueto a fall on a rough surface or rubbing against a surface such as in amotorcycle accident, many pain signals are sent to the brain. A methodof interfering with transmission of pain signals caused by a scrapecomprises a) contacting a device of the present invention with an areaon the surface of a subject between the spinal cord and the site of thescrape, so that at least a portion of the application area of the devicecontacts the area; b) initiating vibration by the device in anintermittent or continuous vibration, and optionally applying a thermaleffect simultaneously with the vibration, by interposing a thermalelement between the application area of the device and the contactedsurface; and c) providing vibrating and/or thermal effect for asufficient time to interfere with nerve transmission to the brain, andto reduce the pain felt from the scrape site. The thermal effect maycold or warm. The device may interfere with transmission of pain signalsby aDelta nerves at the site of the scrape. The device may be placedfrom 0.5 to 15 cm from the scrape site in a location that is between thescrape and the nerve plexus.

An open wound in the skin or underlying structures may be treated bymedical personnel by scraping the wound with a blunt instrument toremove cellular debris or other debris present and this treatment isvery painful, though necessary. A method of interfering withtransmission of pain signals caused by a scraping treatment comprises a)contacting a device of the present invention with an area on the surfaceof a subject between the spinal cord and the site being treated byscraping, so that at least a portion of the application area of thedevice contacts the area; b) initiating vibration by the device in anintermittent or continuous vibration, and optionally applying a thermaleffect simultaneously with the vibration, by interposing a thermalelement between the application area of the device and the contactedsurface; and c) continuing vibration and/or thermal effect at the siteof for a time sufficient to reduce the pain felt from the site beingscraped and treated. The thermal effect may cold or warm. The device mayinterfere with transmission of pain signals by aDelta nerves at the siteof the wound or scraping treatment. The device may be placed from 0.5 to15 cm from the scrape site in a location that is between the scrape andthe nerve plexus.

A method of the present invention comprises treating neuropathic painfrom nerve pain such as an outbreak of herpes simplex or shingles, orphantom pain from a missing limb. A method of interfering withtransmission of neuropathic pain signals caused by viral infection suchas cold sores or shingles, or from phantom limb pain, comprises a)contacting a device of the present invention with an area on the surfaceof a subject between the spinal cord and the site of nerve pain or inthe case of missing limbs, between the spinal cord and the stump, or atthe stump or terminus of the limb, so that at least a portion of theapplication area of the device contacts a portion of the surface area ofthe subject; b) initiating vibration by the device in an intermittent orcontinuous vibration, and optionally applying a thermal effectsimultaneously with the vibration, by interposing a thermal elementbetween the application area of the device and the contacted surface;and c) continuing vibration and/or thermal effect at the site of for atime sufficient to reduce the pain felt from the site. The thermaleffect may cold or warm. The device may interfere with transmission ofpain signals by aDelta nerves at the site. The device may be placed from0.5 to 15 cm from the scrape site in a location that is between thescrape and the nerve plexus.

A burn site in the skin or underlying structures may be treated bymedical personnel and burn treatment may be very painful, thoughnecessary, and the healing period after a burn may be very painful evenif no active treatment is made to the burn area. A method of interferingwith transmission of pain signals caused by treatment of the burn orinterfering with the transmission of pain signals from a burn when noactive treatment is occurring comprises a) contacting a device of thepresent invention with an area on the surface of a subject between thespinal cord and the burn site, so that at least a portion of theapplication area of the device contacts the area; b) initiatingvibration by the device in an intermittent or continuous vibration, andoptionally applying a thermal effect simultaneously with the vibration,by interposing a thermal element between the application area of thedevice and the contacted surface; and c) continuing vibration and/orthermal effect at the site of for a time sufficient to reduce the painfelt from the burn site. The thermal effect may cold or warm. The devicemay interfere with transmission of pain signals by aDelta nerves at theburn site. The device may be placed from 0.5 to 15 cm from the burn sitein a location that is between the burn and the nerve plexus.

Additionally, a burn site may have reduced blood flow into and/or out ofthe burn site. A method of increasing blood flow into and/or out of aburn site comprises a) contacting a device of the present invention withan area on the surface of a subject adjacent to the burn site, so thatat least a portion of the application area of the device contacts thearea; b) initiating vibration by the device in an intermittent orcontinuous vibration, and optionally applying a thermal effectsimultaneously with the vibration, by interposing a thermal elementbetween the application area of the device and the contacted surface;and c) continuing vibration and/or thermal effect at the site of for atime sufficient at least initiate increased blood flow into and/or outof the burn site. Multiple treatments of contacting an area adjacent tothe burn site with a vibratory device of the present invention,optionally comprising a thermal element, may be desired to providecontinued increased blood flow. The thermal effect may cold or warm. Thedevice may provide vibratory effects including increasing blood or lymphflow. The device may be placed from 0.5 to 15 cm from the burn site.

The thermal element is cooled or heated, if necessary to within apredetermined temperature range. The thermal element may be placedwithin or attached to the casing. Alternatively, if the device is madeto certain standards, the entire device already containing a thermalelement can be cooled to the desired temperature. When a subjectanticipates a need for a treatment using the device, the device isapplied to the body at a desired location, such at the site to betreated or at a site proximate to a pain site and between the pain siteand the brain and/or spinal cord, as described for treatments disclosedherein.

When a subject is to undergo a medical procedure, such as infusion of amedicinal solution that causes a burning or painful sensation, orscraping of a wound, or when deemed necessary by a subject, a device ofthe present invention comprising a thermal element may be applied to aselected area of the subject such that the vibrational area contacts thesubject's skin through the thermal element to provide the applicationarea. The optional thermal element may be allowed to act upon thesubject for a time necessary to initiate thermal effects, which can befor a period of seconds up to a period of several minutes or more, ormay be between 0 and 60 seconds. Once suitable thermal effects areachieved, or concurrently when the thermal element is applied to thesubject, the vibrational source is actuated by the on/off switch,creating vibration. The vibrational source also is allowed to act uponthe subject for a time necessary to initiate vibrational effects whichcan be for a period of seconds up to a period of several minutes ormore, or may be from about 0 to about 60 seconds. If prolonged vibratoryand/or thermal treatment is desired the device may be applied for alonger period to provide pain relief or relief from unpleasantsensations. Once the desired outcome is reached, the device may beremoved from the subject, and/or the thermal element can be removed fromacting on the subject and/or the vibrational source can be turned off.However, it is possible to leave the device, including the activethermal element and the active vibrational source in contact with thesubject for prolonged periods of time. For example, the device may beleft in place by using a wrap, and the device is then activated on anon-going schedule of time periods of use of the device and quiescence.One or more thermal elements may be provided to the device to allow forthermal effects to the subject during the periods of use.

“Thermal effects” as used herein includes, but is not limited to, theuse or application of cold or reduced temperature (or the removal ofheat) thermal elements or use of warm or heated thermal elements to asubject to induce a thermal effect, such as increased vascular diameterand increased arterial or venous blood flow, or constriction of vesselsor inhibition of pain transmission

“Vibrational effects” as used herein includes, but is not limited to,the use or application of vibration to a subject to induce vibrationalresponses in the subject, such as an increase in vascular diameter andincreased blood flow from arteries, veins, or capillaries, or blockingof pain transmission by nerves, such as aDelta nerves, or blocking orreducing of burning, itching or other unpleasant sensation transmissionto the brain and/or spinal cord.

“Vibrational and thermal effects” as used herein includes, but is notlimit to, the use or application of either heat or cold or reducedtemperature (or the removal of heat) concurrently, substantiallyconcurrently, or sequentially with the use or application of vibrationto a subject to induce physiological changes in the subject in the areacontacted by a device of the present invention or in a proximal ordistal area.

Referring now to FIG. 1, a perspective view of an embodiment of thedevice is shown as applied to the arm of a subject, showing the casingthat houses the various components of the invention and an optionalstrap for holding the device to the subject In the view, the device (10)is being applied to the surface (100) of a subject who has an initiationsite (104), which is a site of pain or irritating sensation, such asburning or itching. As used herein, an initiation site is a site on abody that has reduced blood flow, reduced lymph flow, blocked ducts, isa site for painful sensations, a site of neuropathic pain, a site forunpleasant sensations including, but not limited to, itching and burningsensations, and those from insect stings, scrapes, or other abrasions toa body surface. For example, the initiation site may have reduced bloodflow and contacting the initiation site with a vibrating and/or thermaleffects providing device of the present invention may increase the bloodflow or cause local vasodilation. For example, the initiation site maybe a wound site, and contacting a site other than the initiation site,such as between the initiation site and the brain and/or spinal cord ofa subject with a vibrating and/or thermal effects providing device ofthe present invention may reduce, impede or prevent transmissions ofpainful stimuli sensations to the brain.

The positioning of the device (10) on the subject is between theinitiation site (104) and a nerve plexi (not shown, but the location ofwhich is known to those of ordinary skill in the medical field) such asbetween the initiation site (104) and the proximal joint, in thisfigure, an elbow (E). Thus, for the illustrated initiation site (104) ona subject's arm (100), the device (10) is placed closer to the elbow (E)than to the wrist (W) as this location puts the device (10) in betweenthe initiation site (104) and the subject's brain. For example, thedevice 10 may be placed approximately 2.5 cm to 15 cm from initiationsite (104). The on/off switch (16) is shown on the distal side of thedevice or casing, and a strap (14) is shown holding the device on thesubject. A cuff, wrap, bandage or other similar component can be used inplace of a strap to hold a device of the present invention on a subject.

The casing (12) may be manufactured of a flexible or pliant materialsuch as for illustrative purposes a natural or synthetic woven ornon-woven fabric, a rubber or other flexible polymer material, asilicone-based material, or may be a rigid material, such as a plastic,metal or wooden casing, wherein the casing is a container with walls todefine an enclosed area. Other flexible or pliant or other materials maybe employed, and it is preferred that the material of construction isnon-toxic, hypo-allergenic and non-staining to the subject. A materialthat will transfer vibrations is contemplated by the present invention.

The casing can be any shape, and preferably is in the shape of athree-dimensional polygon (for use with an adult use) or an animal orother distractive shape (for use with a child) and the casing wallsdefine a interior space or interior sections for containing theoperating elements of the invention. Any other shape (as used herein,the term shape is used in the broad sense of three-dimensional works)may be employed, so long as the shape is large enough and structured soas to be able to contain the various working components of the inventionas more fully disclosed below.

The device is shown in FIG. 1 applied to the arm of a subject having aninitiation site (104), which may be a painful site, such as a burn, ascrape and viral outbreak, or a site of medication infusion that ispainful when infused, or may be a site of itching or other unpleasantand undesired sensation. The positioning of the device on the subjectmay be between the initiation site (104) and a nerve plexi (not shown,but the location of which is known to those of ordinary skill in themedical field) or between initiation site (104) and the spinal cord orbrain. In this example, the device is placed at or proximal to the elbowE. Preferably, the device is placed approximately 2.5 cm to 15 cm fromthe initiation site (104). A thermal element pocket (34) in the casingis illustrated on this embodiment. An embodiment showing the distal sideof the invention of FIG. 1 is shown in FIG. 2, comprising the casing(12) and an on/off switch (16). An optional strap (14) can be used tohold the device on to the subject. Alternatively, the device can be heldagainst the subject by medical personnel, or the subject. The strap (14)can be attached to the casing (12) in any conventional manner or can bean extension of casing itself. For example, the strap and casing can beattached together much like a conventional watch and watchband withhinges or pins. Or in another embodiment, the strap can be an extensionof the fabric or other material enclosing the casing, such as anextension of a decorative cover (shown in FIG. 6). The ends of strappreferably have some type of connection element (18), such as a hook andloop fastener, adhesive, a clasp, a clip, snaps, magnets, or the likefor attaching the device about the subject's body part. Alternatively,if the ends of the strap are flexible, the ends can be tied togetheraround the subject's body part.

Referring now to FIG. 3, a bottom or proximal view of an embodiment ofthe invention of FIG. 1 is shown. The casing (12) has a peripheralbottom rim that defines an application area (22). Application area (22)comprises thermal area (24) and vibration area (26). Although thermalarea (24) and vibration area (26) area shown as discrete areas, this isfor illustrative purposes only, as there need not be any physicaldelineation between thermal area (24), vibration area (26), andapplication area (22) and these areas can overlap and be coexistent asthe same area, which may be referred to as application area (22).Thermal element (28) cooperates with thermal area (24) to apply cold orheat to the subject, and vibrational source (32) (not shown) cooperateswith vibration area (26) to apply vibration to the subject. Thermal area(24) and vibrational area (26) can occupy the same area, can coextendand form application area (22). Thermal element (28) may be locatedwithin thermal element pocket (34). The thermal pocket (34) is a slot,fold or other type of compartment in the casing into which the thermalelement can be placed. As shown in FIG. 3, the thermal element pocket isaccessed on the side of the casing via a mouth or an opening in thecasing. Alternatively, the opening for the pocket can be located atother sites on the casing depending on the size and shape of casing andthe location of the vibrational source within the casing. Alternatively,the thermal element can be contained within the main housing volume ofthe casing. Thus, the placement of the thermal element is variable solong as the cooling or heating effects of the thermal element can befelt on the subject so as to produce thermal effects. Thermal area inits simplest form is an area on the application area on the device thatallows the thermal effects from thermal element to contact the subject.

The vibration area is an area on the casing in vibratory contact withthe vibrational source. As disclosed in more detail below, vibrationalsource preferably is contained within the main housing volume of thecasing. The placement of the vibrational source is variable so long asthe vibration effects of vibrational source can be felt on the subjectso as to produce vibrational effects. As shown in FIG. 3, vibrationalarea is proximal to thermal area; however, vibrational area can coextendwith thermal area. Vibrational area in its simplest form is an area onthe application area on the device that allows the vibrations fromvibrational source to contact the subject.

Referring now to FIG. 4, a sectional side view of the embodiment of theinvention as shown along line 4-4′ of FIG. 2 is shown. The casing (12)is a generally hollow structure sized to contain an optional a thermalelement, and a vibrational source. A casing (12) can be a rigid hollowcontainer having an interior volume or a flexible or pliant containerhaving an interior volume. Such containers are known, as well as theirmaterials and methods of construction are within the skill of those inthe art. The casing may be constructed such that casing (12) can containand hold a vibrational source, and optionally, a thermal source, in apredetermined position relative to the subject when the device iscontacting a subject.

As shown illustratively in FIG. 4, thermal element is contained inthermal element pocket. Thermal element can be placed within thermalelement pocket through mouth or opening and can be held within thermalelement pocket by friction, adhesives, fasteners, or by a zipper orother type of closure on the pocket mouth or opening. It may be desiredthat the bottom wall of thermal element pocket be sufficiently thin orhave sufficient thermal transfer characteristics so as to allow theefficient transfer of cold or heat from thermal element to the subject.Alternatively, a thermal element (28) may be placed on the outsidesurface of the proximal side of a casing so that in use, the thermalelement is interposed between the proximal surface of the casing and thesubject's surface.

Thermal element can be any conventional thermal element capable ofstoring and transferring cold (removing heat). Illustrative examples ofsuitable thermal elements include metal ingots, low freezing point(below about 45° F. or 7.2° C.) liquids and gels, ceramics, polymers,polymer materials, natural materials such as bran, other heat sinks, hotpacks, chemical reactive thermal packs, thermal gel packs, and even icepacks. Such thermal elements are known. It is only important thatthermal element be able to transfer cold or heat to the subject in asufficient amount so as to produce the desired effect, for examplevasodilation, pain reduction, itching sensation reduction, or reductionin blocked vessels. For example, providing a temperature of below about45° F. or 7.2° C., and between about 28° F. or −2.2° C. and about 54° F.or 12.2° C., or between about 38° F. or 3.3° C. and about 45° F. or 7.2°C., or for example about 34° F. to the subject prior to and during thetreatment method is sufficient to provide a suitable level of effectivethermal treatment. The thermal element is applied to the subject for atime period sufficient to initiate treatment, such as thermalvasodilation, which can be between 0 seconds and several minutes or moredepending on the subject. For example, in some applications, it isdesirable to apply the thermal element to the subject for a period ofabout 0 to 60 seconds, or longer, prior to initiating an activity, suchas injecting a medication that causes a painful or burning sensation, orscraping of a wound, and continuing the application of the thermaleffect and/or vibration during the activity to provide a suitable levelof effective treatment by the device.

The thermal element may be any conventional thermal element capable ofstoring and transferring heat or cold. Illustrative examples of suitablethermal elements include high specific-heat capacity material likegrains, such as wheat or buck wheat, sewn within an insulated fabricsuch as flannel, chemical thermal elements like calcium chloride- orsupersaturated sodium acetate-based heat pads, or other conventionalheat/cold packs. A thermal element may be a gel or other type ofheat/cold pack that may be placed in a freezer or microwave and suchheat/cold packs are known in the art. The present invention contemplatesuse of thermal elements that are known in the art. The thermal elementneeds to transfer heat or cold to the subject in a sufficient amount soas to produce the desired effect of such heat or cold, for examplevasoconstriction or vasodilation. One of skill in the art, such asmedical personnel, or a subject, can determine an adequate temperatureand time for application of the thermal element for methods disclosedherein. The thermal element is applied to the subject for a time periodsufficient to cause the desired effect, which can be between 0 secondsand several minutes or more depending on the subject and/or the method.A second or third thermal element may be used in replacing a firstthermal element used in a method, especially in methods whereapplication of vibration and/or thermal effects continue for a longertime period than the first thermal element can maintain the desiredtemperature.

As shown illustratively in FIG. 4, the vibrational source (32) iscontained within the interior of the casing (12). Vibrational source(32) can be placed within casing (12) during manufacture or at any timeafter manufacture. An ingress and egress element (90) is preferred, asone embodiment of vibrational source utilizes a battery as the powersource, and it may be necessary to change the battery on occasion. SeeFIG. 9C where an ingress/egress element (90), as illustrated, is ascrew, is shown for opening the casing (12), and may be used for holdinga control board, and/or power source and/or vibrational source (motor),or other components on a control board in the interior of the casing(12). Ingress/egress element (90) can be a snap, a screw, a bolt, or anyclosure components that would releasably hold the casing closed andallow for access to at least a power source within the casing.Vibrational source (32) and power source (40) can be held within casingby friction, adhesives, fasteners, or other types of securing means.Alternatively, the interior volume of casing can be approximately thesame dimensions as the vibrational source, including the power source,such that additional means for securing the vibrational source 28 areunnecessary. In an aspects, the proximal side (30) of the casing whichis adjacent to vibrational source be sufficiently thin or havesufficient vibrational transfer characteristics so as to allow theefficient transfer of vibration from vibrational source to theapplication area (22) of the casing (12) and thus to the subject to betreated in the methods disclosed herein.

Vibrational source (32) can be any conventional vibrational source ormeans for producing vibrations. As shown in FIG. 4, vibrational sourcefurther comprises a power source (40) and wiring electrically connectingvibrational source and power source to an on/off switch. Illustrativeexamples of suitable vibrational sources include elliptical flywheelmotors, eccentric motors, and the like. Such vibrational sources areknown. It is only important that the vibrational source be able totransfer vibration to the subject at a sufficient level to produce theeffect intended in the disclosed methods. For example, a device of thepresent invention can provide vibrations of between about 175-250 Hz.The application area of the device which vibrates due to the action ofthe vibrational source is applied to the subject for a time periodsufficient to accomplish the effect intended in the disclosed methods,which can be between 0 seconds and several minutes or more depending onthe subject and/or the method. For example, the application area of thecasing may provide vibration to the subject for a period of about 0seconds to about 60 seconds, or longer in certain methods, to accomplishthe effect intended in the disclosed methods. A vibrational source maybe a high frequency low amplitude eccentric motor. The motor may becontrolled by a logic control board, such as a polycarbonate board,which known in the art. The motor and/or a power source may be held to aboard by brackets, screws or other known attachment elements.

A vibrational source can produce a single vibrational cycle, multiplevibrational cycles, or be variable, for example in the vibrations perminute in a particular cycle, or in the number of vibrational cycles. Inother words, the vibrational source can be a vibrational motor thatoperates at, for example, 4700 vibrations per minute or, for anotherexample, at 5700 vibrations per minute, or in a range from about 6,000to about 15,000 vibrations per minute, or from about 8,000 to about14,000 vibrations per minute, or from about 9,000 to about 13,000vibrations per minute, or any vibrations per minute thereinbetween.Alternatively, vibrational source can be a vibrational motor thatoperates at two or more vibrational cycles, for example, 9,000vibrations per minute and 13,000 vibrations per minute, and can beswitched between vibrational cycles by a switch or other controlelement. Alternatively, vibrational source can be a vibrational motorthat operates at many different vibrational cycles along a continuum byusing a potentiostatic switch, for example, vibrational source can bevaried continuously or step-wise between 3000 vibrations per minute and15,000 vibrations per minute. In an aspect, the vibrational source mayprovide intermittent vibration cycles, which may be the same ordifferent vibrations per minute. For example, a vibrational source mayprovide 10,000 vibrations a minute for 4 seconds, stop vibrating for 4seconds, thus completing one cycle of vibrations, then provide anothercycle of vibrations at 10,000 vibrations a minute for 4 seconds, stopvibrating for 4 seconds, and so on. The vibrations per minute may remainthe same for each cycle, or may vary randomly or vary in an increasingor decreasing manner. The time of vibration may vary randomly for eachcycle, or may vary in an increasing or decreasing manner. The time of novibration may vary randomly for each cycle, or may vary in an increasingor decreasing manner.

A switch may be a common switch and is used to turn the vibrationalsource on and off, namely to start and stop the vibration, respectively.The switch may also control power transmission to a control element orother element of the device, such as a sound element or a light. Theswitch can be secured to the casing at any convenient position where itmay readily be actuated, or accessed remotely by wired or wirelesscomponents. As shown in FIG. 9, the switch is located at the anteriorside (31) of the device and is a push button switch. The switch iselectrically connected in a known manner between the power source andthe vibrational source to control the application of power to thevibrational source. In an aspect, when the vibrational source isswitched on, the vibrating force produced from the vibrational source,such as the various types of motors disclosed above, will be transmittedthrough the casing to the contacted surface.

A device of the present invention may have more than one switch, each ofwhich may control the power to an element of the device, or provideon/off control of the element itself, and discussion of one switch isnot to be seen as limiting to the invention. A switch can be a commonon/off switch, such as a toggle, lever, push-button, capacitance orother switch. This type of switch would be practical with a singlevibrational cycle motor. Alternatively, switch can be a common three-wayswitch. This type of switch would be practical with a double vibrationalcycle motor. Alternatively, a switch can be a common potentiostat. Thistype of switch would be practical with a vibrational motor that operatesat many different vibrational cycles along a continuum. The selection ofthe type of switch and the control element of a device is within theskill of those knowledgeable in the art. For example, a switch can turnpower on or off to a control panel that in turn controls a vibrationsource, and/or other elements of the device, such as sound or lightelements.

Referring now to FIG. 5A, a representative circuit diagram for thevibrational source is shown. Vibrational source, power source and on/offswitch are electrically connected in series by wiring. Power source isillustrated in FIG. 5 as a battery; however, power source can be anytype of power sources such as but not limited to a connection to analternating current source (a wall plug), a solar or other light cell, areactor, a mechanical source such as a flywheel or springs, or the like.It is only important that power source be able to provide sufficientpower to vibrational source so as to produce sufficient vibration foreffecting vibrational vasodilation. FIG. 5B is a circuit diagram of anembodiment of the present invention comprising a vibrational source(32), a push button on/off switch (16), a battery power source (40), acontrol board (45), and optionally a speaker (46) and a light (47), inelectrical connection in series by wiring (42).

In operation and use, a device of the present invention is effective inachieving the methods disclosed herein. According to known gate theory,vibration helps to reduce pain as the vibrational or motion nervessurmount the pain nerves. Similarly, it is known that cold helps toreduce pain as the temperature nerves surmount the pain nerves. It alsois known that warm thermal contact is effective at vasodilation. It alsois believed that vibrational and thermal vasodilation is more effectivewhen applied generally between the pain source or an initiation site andthe brain, and more specifically close to the nerve plexi where thevarious nerve types (pain, temperature and motion) converge in the body,generally at or proximal to a joint.

A thermal element is cooled or heated, as necessary. For example, if thethermal element is a metal ingot or low freezing point gel, the thermalelement is placed in a refrigerator, freezer, or other cold site.Alternatively, if the thermal element is a high specific-heat capacitymaterial like a grain sewn within an insulated fabric it may bemicrowaved before use to heat it. When the thermal element is of asatisfactory temperature, the thermal element is placed within oradjacent to the casing. The thermal element may be placed within thethermal element pocket, within an attachment element (50) such as anelastic band attached to the casing so that the thermal element isinterposed between the elastic band and the proximal side (30) of thedevice, or within an attachment element (50) such as a clip located onthe proximal side of the device as shown in FIGS. 9A-C and E. The deviceis contacted to the surface, such as the surface of skin of a subject,at the desired location, depending on the method employed for thedesired treatment. In the example shown in FIG. 1, where a site ofinjection is proximal to the subject's wrist, the device is contactedbetween the injection site and the subject's brain, and morespecifically in the illustrative example shown in FIG. 1, is placedbetween the initiation site and the subject's elbow and proximal to thenerve plexi proximal to the elbow. In other methods, the device maycontact the initiation site directly and not be adjacent to it, asdescribed for certain disclosed methods.

The application area of the device, with the thermal element interposedtherebetween, is applied to the selected area of the subject such thatthe application area, comprising the thermal area and the vibrationalarea, contact the subject's skin. The thermal element may be contactedwith the surface for a time period, without vibration, for example, toallow the thermal element to act upon the subject for a suitable timeperiod so as to initiate thermal effects, for example, vasodilation orvasoconstriction. Alternatively, concurrently with application of thethermal element to achieve thermal effects, the vibrational source isactuated, for example, by pressing the switch, and starting thevibrational source, and vibrations are transferred through theapplication area (and through the thermal element if present) to thecontacted surface. The vibrational source also is allowed to act uponthe subject for a suitable time period so as to initiate the desiredeffect depending on the method of application. After thermal andvibrational effects are initiated, a treatment may occur to the subjector the vibrational and thermal effects may be continued until pain oritching sensations are no longer perceived by the subject.

Once the desired treatment is completed, vessel diameters have beeneffected, or the sensations are no longer perceived by the subject, theentire device can be removed from contacting the surface, and/or onlythe thermal element can be removed and the device continues to providevibration to the surface, or the thermal element may remain in place onthe surface and the vibrational source may be turned off. In oneillustrative method, the device is left in contact with the subject fora period of between 0 and 60 seconds, or for one or more minutes, tocontinue to reduce any pain associated with the site.

Referring now to FIG. 6, alternative embodiments include casings havinginteresting or distracting shapes or ornamental covers (60) over thecasing. Distraction may help reduce pain, especially in children. Forexample, the casing could be a material in the shape of a bumble bee, asillustrated in FIG. 6, or dinosaur. When the device is applied to achild, the distracting shape both can lessen the fear a child may haveto device medical procedure and help to decrease the subsequent pain orunpleasant sensations of the child.

Referring to FIG. 7, a proximal view of a device 10 of the presentinvention comprising a thermal element 28 (shown as transparent so as toview the proximal side 30 of the device 10). An attachment element 50(an elastic band) is shown holding the thermal element 28 to theapplication area 22 of the proximal side 30 of the casing 12 of thedevice 10.

FIG. 8 shows the placement of a device of the present invention 10 onthe arm of a human in a location between an initiation site 104 and thebrain/spinal cord of the human.

FIG. 9 A-E shows a drawing of an exemplary device of the presentinvention having a shaped casing. 9A shows the front or anterior end(31) of the device (10) and its power switch (16), B shows the posterioror rear end (33) of the device (10) with its site indicator (52), and 9Cshows the back or proximal side (30) of the device, that is contacts, oris placed proximally or adjacent to, the surface, having a clip (50) forholding a thermal element (not shown) in place. The distal side (30) maybe flat or planar in shape, or may be curved, as desired. D shows afront or distal side (37) of the device (10), and E shows a side view(35 a or 35 b) of the vibratory device (10) where the attachment element(50) a clip, slightly protrudes from the posterior (lower) (33) proximalend and the on/off switch element (16) is shown at the anterior (upper)end (31). The site indicator (52) provides a guide to the user forplacing the device. In methods where applicable, the device is placed sothat the indicator is directly at the site of injection, pain, treatmentor itching sensation. 9C shows the proximal side 30 of the device 10.For example, the entire proximal side may be the application area 22 andthe entire proximal side (30) substantially contacts the surfacecontacted and the proximal side (30) comprises the application area 22through which vibration is transferred to the surface. In an aspect,only a portion of the proximal side may be the application area. Alsoshown is attachment element, 52, which is a clip. The indicator 50 isalso shown. FIG. 9D shows the distal side 37 of the device which may becurved in a shaped manner to fit comfortably in a hand when gripped. Thelateral sides 35 A and 35 b are shown as indented in a generally midlineposition. Other shapes are contemplated by the invention and theindentions may or may not provide a functional or a decorative aspect tothe invention. FIG. 9E shows a lateral side 35 a/b view of the device10. At the anterior end 31 the switch 16 is visible. The attachmentelement (clip) 50 is visible on the proximal side 30. The shape of thedistal side (37) may be any desired shape, and may be in someembodiments flat or planar, or may be curved, either convex or concavein shape.

Thus, in one of its simplest forms, the invention is a device forproviding vibration and/or thermal treatment to a surface, comprising acasing comprising an application area, wherein at least a portion of theapplication area is shaped to substantially contact a surface, such as asubject's skin, a vibrational source contained within the casing, withsaid vibrational source capable of producing vibration that is transferthrough the casing to at least the surface, and optionally comprising athermal element capable of transmitting heat or cold. The applicationarea is constructed to allow the transmission of vibration from thevibrational source to the surface, such as a subject's skin, and by theinterpositioning of a thermal source between the application area andthe surface, providing thermal effects to the surface. The vibration orcombination of the vibration and transmission of cold or heat from thethermal element produces vibrational and thermal effects on the subject.

The invention further comprises the use of a removable thermal element.For example, the casing may comprise a flat hook on which a thermal packcould be attached while still transmitting vibrational energy if thepack were soft.

The invention further comprises a vibrational unit with a power sourcecapable of being attached via an adhesive dressing (e.g. tegaderm) orattached to the skin in an array of vibrational units.

The present invention may comprise a kit comprising a vibratory deviceof the present invention, a thermal element and an instructions for useof the device.

As used herein, subject means a human or animal, and includes any livinganimal on the planet Earth.

The above detailed description of the preferred embodiments, and theexamples, are for illustrative purposes only and are not intended tolimit the scope and spirit of the invention, and its equivalents, asdefined by the claims. One skilled in the art will recognize that manyvariations can be made to the invention disclosed in this specificationwithout departing from the scope and spirit of the invention.

REFERENCES

-   Baxter A L, Leong T, Mathew B. External Thermomechanical Stimulation    versus Vapocoolant for Adult Venipuncture Pain: Pilot Data on a    Novel Device. Clin J Pain 2009; 25(8):705-710.-   Baxter A L, Cohen L L, Lawson M L, Von Baeyer C L. A Randomized    Clinical Trial of a Novel Vibrating Tourniquet to Decrease Pediatric    Venipuncture Pain. Pediatr Emerg Care 2011; 27(12):1151-6.-   Bovenzi M, Lindsell C J, Griffin M J. Duration of acute exposures to    vibration and finger circulation. Scand J Work Environ Health 1998;    24(2):130-7.-   Figueroa A, Gil R, Sanchez-Gonzalez M A. Whole-body vibration    attenuates the increase in leg arterial stiffness and aortic    systolic blood pressure during post-exercise muscle ischemia. Eur J    Appl Physiol 2011; 111(7):1261-8.-   Figueroa A, Gil R, Wong A, Hooshmand S, Park S Y, Vicil F, et al.    Whole-body vibration training reduces arterial stiffness, blood    pressure and sympathovagal balance in young overweight/obese women.    Hypertens Res 2012.-   Freeman A W, Johnson K O. A model accounting for effects of    vibratory amplitude on responses of cutaneous mechanoreceptors in    macaque monkey. J Physiol 1982; 323:43-64.-   Hess H A. A biomedical device to improve pediatric vascular access    success. Ped Nurs 2010; 36(5): 259-263.-   Inal S, Kelleci M. Buzzy relieves pediatric venipuncture pain during    blood specimen collection. MCN Am J Matern Child Nurs 2012; in    press.-   Skoglund C R. Vasodilatation in human skin induced by low-amplitude    high-frequency vibration. Clin Physiol 1989; 9(4):361-72.-   Spandorfer P R, Alessandrini E A, Joffe M D, Localio R, Shaw K N.    Oral versus intravenous rehydration of moderately dehydrated    children: a randomized, controlled trial. Pediatrics 2005;    115(2):295-301.-   Taddio A, Soin H K, Schuh S, Koren G, Scolnik D. Liposomal lidocaine    to improve procedural success rates and reduce procedural pain among    children: a randomized controlled trial. Cmaj 2005; 172(13):1691-5.-   Thompson A J, Griffin M J. Effect of the magnitude and frequency of    hand-transmitted vibration on finger blood flow during and after    exposure to vibration. Int Arch Occup Environ Health 2009;    82(9):1151-62.

What is claimed is:
 1. A method for increasing fluid flow in a site ofreduced fluid flow in a subject, the method comprising contacting avibratory device at or adjacent to a site of reduced fluid flow, whereinthe vibratory device comprises a) a casing comprising an applicationarea, b) a vibrational source contained within the casing, wherein thevibrational source is capable of producing vibration, c) a switchsecured to the casing and in operative communication with thevibrational source for selectively activating the vibrational source,and d) a thermal source capable of being cooled; initiating vibration bythe device, optionally providing a thermal effect simultaneously withthe vibration, and modulating the fluid flow in the site of reducedfluid flow.
 2. The method of claim 1, wherein the reduced fluid flow isreduced blood flow in tissue at or adjacent to an injured, wounded orburned site.
 3. The method of claim 1, wherein the reduced fluid flow isa blocked duct, a pulmonary passage, a mammary duct, or a blockedartery, vein or capillary.
 4. A method for reducing pain or irritatingsensation at an initiation site of such sensations, the methodcomprising contacting a vibratory device at a first site between thespinal cord and the initiation site of the pain or irritating sensation,wherein the vibratory device comprises a) a casing comprising anapplication area, b) a vibrational source contained within the casing,wherein the vibrational source is capable of producing vibration, c) aswitch secured to the casing and in operative communication with thevibrational source for selectively activating the vibrational source,and d) a thermal source capable of being cooled; providing vibration bythe device in an intermittent or continuous vibration, optionallyapplying a thermal effect simultaneously with the vibration, andvibrating for a sufficient time to interfere with nerve transmissionfrom the initiation site.
 5. The method of claim 4, further comprising,after contact at the first site, moving the vibratory device to theinitiation site of sensation, and initiating vibration at the initiationsite for a time sufficient to reduce the sensations felt from theinitiation site; and optionally applying a thermal effect simultaneouslyto the initiation site.
 6. The method of claim 4, further comprisingremoving the vibratory device from contact with the subject, optionallyafter affecting a cessation of sensations or nerve transmission from theinitiation site.
 7. The method of claim 4, wherein the pain or sensationis itching, burning, an insect bite, or pain from a wound, a scrape, aburn or an abrasion to the surface of the subject.